Referring to the Drawings, and particularly to FIG. 1 thereof, there is shown a human stomach 10 having an adjustable gastric band 12 secured therearound. As is well known to those skilled in the art, the adjustable gastric band 12 typically includes an outer flexible, substantially non-extendable layer 14 and an inner expandable layer which is secured to the outer layer 14.
In use, the adjustable gastric band 12 is extended around the stomach 10 at the location shown in FIG. 1. The adjustable gastric band 12 is then secured in place by joining the opposite ends of the flexible, substantially non-extendable layer 14 utilizing a latch. When the adjustable gastric band 12 is thus secured in place the stomach is divided into a relatively small upper portion 16 and a relatively larger lower portion 18.
The adjustable gastric band 12 is provided with a tube 20 which extends through an incision made in the abdominal wall of the patient to a location outside of the abdominal cavity. Sterile saline is directed through the tube 20, through a valve, and into the expandable inner layer of the adjustable gastric band 12 thereby causing the expandable inner layer to balloon inwardly. In this manner the passage of food from the upper portion 16 to the lower portion 18 of the stomach 10 is restricted.
It is theorized that the upper portion 16 of the stomach 10 and/or the adjacent lower region of the esophagus contains nerve endings which trigger a “full” feeling when the stomach 10 is full. When the adjustable gastric band 12 is positioned as illustrated in FIG. 1 and when the flexible inner wall of the adjustable gastric band is inflated, food accumulates in the upper portion 16 and in the adjacent lower region of the esophagus. This causes the patient to experience a “full” feeling even though the lower portion 18 of the stomach 10 is in fact not full. Because the patient experiences a “full” feeling after consuming a relatively small amount of food the patient's total caloric intake is reduced thereby facilitating control of the patient's obesity. As is understood by those skilled in the art, the inner flexible layer of the adjustable gastric band 12 is further expanded as the obesity treatment progresses thereby further restricting the passage of food from the upper portion 16 to the lower portion 18 of the stomach 10.
In between about 3% and about 5% of the 40,000+ cases annually in which an adjustable gastric band is used in the treatment of morbid obesity the adjustable gastric band 12 moves downwardly relative to the stomach 10, an occurrence known as a slip. When an anterior slip occurs the adjustable gastric band moves into the improper vertical orientation illustrated in FIG. 2 as opposed to the proper angular orientation illustrated in FIG. 1. A slip of the type illustrated in FIG. 2 is dangerous because it results in food accumulating in the upper portion 16 of the stomach 10 rather than flowing smoothly from the upper portion 16 to the lower portion 18 of the stomach 10 albeit at a slower than normal rate. Accumulation of food in the upper portion 16 of the stomach 10 can cause the patient to experienced frequent vomiting. More importantly, a slip directly restricts blood flow to the herniated portion of the stomach which can cause necrosis thereof which can lead to a surgical emergency and possibly death.
As is also well known to those skilled in the art a posterior slip of the adjustable gastric band 12 relative to the stomach 10 can also occur. The undesirable results of a posterior slip are substantially the same as those described above in conjunction with the slip illustrated in FIG. 2.
FIG. 3 illustrates a prior art technique for preventing movement of the adjustable gastric band 12 relative to the stomach 10. A flap comprising part of the lower portion 18 of the stomach 10 is secured to the upper portion 16 by a plurality of sutures 22. So long as the flap remains sutured to the upper portion 16 of the stomach 10 the adjustable gastric band 12 is secured against significant movement relative to the stomach. However, as is well known to those skilled in the art, various occurrences can cause the flap to become disengaged from the upper portion 16 of the stomach 10. For example, the sutures 22 can simply tear loose. It is also possible that the knots which secure the sutures 22 in place will fail either by becoming untied or due to breakage. It is also possible that the sutures will deteriorate under the action of fluids contained within the stomach 10 and/or within the body cavity.
The present invention comprises a method of and apparatus for preventing movement of an adjustable gastric band relative to the stomach upon which the adjustable gastric is installed. In accordance with the broader aspects of the invention, an adjustable gastric band is positioned on a stomach in the conventional manner and is thereafter sutured to the stomach thereby eliminating the possibility of movement of the adjustable gastric band relative to the stomach.
In accordance with a first embodiment of the invention a plurality of tabs are formed integrally with the flexible, substantially non-extendable layer of an adjustable gastric band and are provided with suture receiving holes to facilitate suturing of the adjustable gastric band to the stomach. In accordance with a second embodiment of the invention, lengths of suture material secured to the flexible, substantially non-extendable outer layer of an adjustable gastric band to facilitate suturing of the adjustable gastric band to the stomach.
In accordance with a third embodiment of the invention, the flexible, substantially non-extendable layer of an adjustable gastric band is provided with a plurality of tabs each having a suture receiving hole formed therein and with a plurality of loops formed from suture material for facilitating suturing of the adjustable gastric band to the stomach. In accordance with a fourth embodiment of the invention a plurality of tabs are secured to the flexible, substantially non-extendable layer of an adjustable gastric band and are provided with suture receiving apertures thereby facilitating suturing of the adjustable gastric band to the stomach. In accordance with a fifth embodiment of the invention a length of fabric is secured to the flexible, substantially non-extendable layer of an adjustable gastric band and is provided with a plurality of apertures extending therethrough for facilitating suturing of the adjustable gastric band to the stomach.